A Study to Investigate the Pharmacokinetics (PK), Tolerability and Safety of Two Different Dupilumab Drug Products in Healthy Participants.

Healthy Volunteers Clinical Trial

Official title:

A Randomized, Open-label, Parallel Design Study of the Pharmacokinetics, Tolerability and Safety of Two Different Dupilumab Drug Products After Administration of Single Subcutaneous Doses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05976373
• Other study ID #: PKM14271
• Secondary ID: U1111-1290-9387
• Status: Completed
• Phase: Phase 1
• Start date: January 5, 2015
• Est. completion date: March 30, 2015

Study information

• Verified date: July 8, 2023
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a phase 1, single subcutaneous dose study to evaluate safety and pharmacokinetic of 2 different dupilumab drug products in adult healthy volunteers. The duration per participant is up to 11 weeks.

Description:

Duration per participant is up to 11 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: March 30, 2015
• Est. primary completion date: March 30, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male or female participants, between 18 and 65 years of age, inclusive.

• Body weight between 70.0 and 90.0 kg, inclusive.

• Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).

• Having given written informed consent prior to undertaking any study-related procedure.

Exclusion Criteria:

• Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness.

• Frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month).

• Blood donation or collection totaling more than 250 mL (including collections during study screening) within 2 months before inclusion on Day -1.

• Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood pressure =20 mmHg within 3 minutes when changing from supine to standing position.

• History of light-headedness or syncope during blood collection or injection of medications.

• Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.

• History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day on a regular basis).

• If female, pregnancy (defined as positive ß-human chorionic gonadotropin (HCG) blood test) or breast-feeding.

• Participation in any clinical research study evaluating another investigational drug or therapy within 30 days or 5 elimination half-lives of the respective investigational drug, whichever is longer, of the inclusion visit.

• Any participant who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Dupilumab (SAR231893)
injection solution subcutaneous

Locations

Country	Name	City	State
United States	Prism Research-Site Number:840001	Saint Paul	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum serum concentration of functional dupilumab (Cmax)		Pre-dose on Day 1 up to Day 57
Primary	Time to reach Cmax (Tmax)		Pre-dose on Day 1 up to Day 57
Primary	Area under the serum concentration versus time curve from time zero to the real time of last measurable concentration (AUClast)		Pre-dose on Day 1 up to Day 57
Secondary	Incidence of treatment-emergent adverse events (TEAEs)		Day 1 up to Day 57
Secondary	Incidence of anti-dupilumab antibodies (ADA)		Day 1 up to Day 57